Actively Recruiting
Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)
Led by Tang-Du Hospital · Updated on 2026-04-01
20
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if Ensartinib combined with chemotherapy works as a neoadjuvant treatment for patients with stage II-IIIB (N2) ALK-positive non-small cell lung cancer (NSCLC). It will also learn about the safety of this combination therapy. The main questions it aims to answer are: * Does Ensartinib combined with chemotherapy lead to a pathological complete response (pCR) in surgically removed tumor tissue after neoadjuvant treatment? * What medical problems do participants have when taking Ensartinib combined with chemotherapy? This is a single-arm study, meaning all participants will receive the investigational treatment. There is no placebo or active comparator group. The study will be conducted in two stages; the second stage will proceed only if no special, unexpected, or serious adverse events related to Ensartinib occur during the first stage involving 5 participants. Participants will: * Receive neoadjuvant treatment with Ensartinib (taken orally once daily) plus Pemetrexed and Carboplatin (administered intravenously every 3 weeks) for 9 weeks (3 cycles). * Undergo surgical resection within 4 weeks after completing neoadjuvant therapy. * Attend regular clinic visits for check-ups, blood tests, and imaging scans (CT, MRI) according to a detailed schedule during the neoadjuvant, surgical, and long-term follow-up periods (up to 10 years). * Be monitored for adverse events and survival outcomes.
CONDITIONS
Official Title
Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent prior to any study-specific procedures.
- Aged between 18 and 75 years old (inclusive).
- Histologically or cytologically confirmed lung adenocarcinoma via biopsy performed within 60 days prior to study enrollment.
- Surgically resectable Stage II-IIIB (N2) lung adenocarcinoma (AJCC 8th Edition TNM Staging).
- Confirmed ALK fusion mutation by detection methods recommended by NCCN guidelines.
- Presence of at least one accurately measurable lesion, with the longest diameter 610 mm on baseline CT scan or lymph nodes with a short axis 615 mm, suitable for accurate repeated measurements.
- ECOG performance status of 0-1.
- Adequate hematological, biochemical, and organ function including hemoglobin 690 g/L (can be maintained or exceeded via transfusion), absolute neutrophil count 61.5x10^9/L, platelet count 690x10^9/L, total bilirubin 62x upper limit of normal, ALT and AST 62.5x upper limit of normal, creatinine 61.5x upper limit of normal, and creatinine clearance 660 mL/min.
- Adequate cardiopulmonary function suitable for surgery as assessed by ECG, echocardiography, pulmonary function tests, or blood gas analysis.
- For women of childbearing potential: Use of effective contraception for at least 2 weeks prior to study drug, negative pregnancy test, and not breastfeeding. Alternatively, documented non-childbearing status as defined by menopause or surgical sterilization.
- For men with partners of childbearing potential: Agreement to use effective contraception during the study and for 3 months after last dose.
You will not qualify if you...
- Presence of squamous cell carcinoma, large cell neuroendocrine carcinoma, or small cell carcinoma components.
- Prior exposure to other anti-tumor therapies before enrollment.
- Patient is pregnant or breastfeeding.
- Current use of or inability to stop drugs or supplements that strongly induce CYP3A4 at least 3 weeks before treatment.
- Severe or uncontrolled systemic disease including uncontrolled hypertension, active bleeding, or active infections such as hepatitis B, hepatitis C, or HIV.
- History of interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring steroids, or current active ILD.
- History of hypersensitivity to Ensartinib or similar drugs, severe nausea/vomiting, gastrointestinal diseases affecting drug absorption, or prior extensive bowel surgery.
- Intolerance to chemotherapy or refusal of chemotherapy.
- Cardiac issues including prolonged QTc interval >470 msec, significant ECG abnormalities, or risk factors for arrhythmia.
- History of neurological or psychiatric disorders such as epilepsy or dementia.
- Any other condition deemed unsuitable for enrollment by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tangdu Hospital
Xi’an, Shanxi, China, 710038
Actively Recruiting
Research Team
Y
Yan xiaolong Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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